Study Finds Single Dose of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels
Thursday March 20, 7:00 am ET
- HHS Now Reviewing Data to Determine Next Steps in $128 Million Contract -
GAITHERSBURG, Md., March 20 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI - News) today announced positive interim results from the 500-subject Phase 1/2 trial of its immunostimulant adjuvant patch used with an injected vaccine for H5N1 influenza. The trial met a key endpoint, demonstrating a clinically relevant adjuvant effect when the Iomai patch was used with a single dose of the 45-microgram H5N1 vaccine. The trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai patch, was sufficient to provide an immune response considered protective in 73 percent of those tested, a statistically significant improvement over those who received the H5N1 influenza vaccine alone.
This is one of the first trials to demonstrate that a single dose of pandemic influenza vaccine may meet the level of protection suggested in U.S. Food and Drug Administration guidance, which recommends that a pandemic vaccine achieve immune response levels considered protective in 70 percent or more of vaccine recipients. The trial was conducted under a $14.5 million contract with the U.S. Department of Health and Human Services (HHS) with the potential for an additional $114 million in follow-on funding. Iomai has shared the data with HHS and is now working with them to determine the next steps.
The only FDA-approved vaccine in the United States for the avian influenza H5N1 virus requires two 90-microgram doses, administered 28 days apart, to achieve hemagglutinin inhibition (HI) titers equal to or greater than 40 in 44 percent of vaccinated individuals.
"During an influenza pandemic, public health officials will face two large hurdles. The first is the possibility of limited vaccine stocks. The second is the logistic difficulty of administering two vaccinations over a period of several weeks to all individuals in the face of a pandemic. This new research clearly indicates that a single dose of vaccine in combination with an Iomai patch could provide a significant level of protection, achieve protective levels more rapidly, and increase compliance," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "This is a major breakthrough and could provide public health officials with an important solution for this looming problem."
The trial tested three different dose levels of Solvay Biologicals, B.V. (Netherlands) egg-derived H5N1 influenza vaccine, the adjuvant patch and placebo to determine which combinations would be most effective in a two-immunization regimen, administered 21 days apart. Data showed that 92 percent of the 50 subjects vaccinated a single time with the 45-microgram dose in combination with the Iomai patch had an immune response. Seventy-three percent of those subjects achieved an HI titer of greater than 40, which is considered protective, offering the potential to eliminate the need for a second vaccination. About 49 percent of those who received the vaccine alone, without a patch, had an immune response considered protective after the first dose, and the 24 percentage point difference between the patch and no-patch groups was statistically significant (p<0.0001). A second dose of both vaccine and patch further enhanced immunogenicity; 100 percent of subjects who received two 45-microgram doses of vaccine and two Iomai patches had a measurable immune response, and 94 percent of subjects had immune responses considered protective.
No treatment-related serious adverse events were reported.
With further testing, the patch has the potential to be used in conjunction with other injected pandemic influenza vaccines. It has been shown to be suitable for ambient temperature shipping and handling, and has at least a 2-year storage shelf life, making the product ideal for stockpiling and rapid distribution. The patch is easily applied and acts like an adhesive bandage placed at the site of the injection.
"This data also confirms our general approach of using an adjuvant patch to improve the immune response to injected vaccines and the ability of our adjuvant to safely and effectively stimulate robust immune responses via the skin," said Gregory Glenn, Iomai's Chief Scientific Officer. "We continue to explore ways to bring this approach to other applications in the high-value field of vaccine adjuvants."
surf's up......crikey
